The Dry Eye Tool Box:

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1 The Dry Eye Tool Box: The professional APP to improve your dry eye management, your patients` loyalty and compliance and to decrease drop-out rate in contact lens wearers. This Tablet-APP gives you the answers to the fundamental questions: Is this a dry eye patient? What is the patient`s dry eye type? What are the best management options for the analysed dry eye type? How can we measure management success? Will the patient claim dry eye symptoms after contact lens fitting? What are the best contact lens options for symptomatic contact lens wearers? How can we measure success after a contact lens update? This is an evidence based APP easily and comfortable to be used with optimal involvement of your patient in the dry eye assessment. This APP leads you through a professional dry eye management scheme making dry eye evaluation and management easy and repeatable. The patient can easily be involved in this process to highlight your professionalism and improve patient loyalty and compliance. Please note: This software aims to assist professionals in the evaluation and management of mild to moderate dry eye. It cannot replace the professional skills and profound knowledge of an eye doctor. Please note the importance of a comprehensive patient history, observations, treatment plans and potential differential diagnoses. It cannot be guaranteed that this software will save or backup any data during its use and that data will not retrievable thereafter. The user of this software accepts any liability and responsibility when using this software. The user declares and accepts to use this software in agreement with local legislations and regulations. The developer warrants no liability. Copyright of the APP, the manual and images are solely with Dr. Heiko Pult, Weinheim, Germany. Any copying, misusing and forwarding to third parties is prohibited. Based on recent data protection of many countries the user is responsible for anonymous data handling, especially submitting data by , cloud or similar and the user being responsible for data back-up. To support the user to not offence against the law we decided not to include a full database. Thank you for your sympathy.

2 Table of Contents Table of Contents... 2 Required technical equipment:... 3 Screening Module:... 4 Non-Contact Lens Wearer:... 4 Naïve-Contact Lens Wearer:... 4 New Contact Lens Wearer:... 5 Dry Eye Manager:... 5 Non-Contact Lens Wearer:... 5 Naïve / Experienced Contact Lens Wearer:... 6 Contact Lens Recommendation:... 6 Coexisting Dry Eye:... 6 Symptometer:... 6 Description of Dry Eye Tests:... 7 Ocular Surface Disease Index:... 7 Lids:... 7 Lid-Parallel Conjunctival Folds:... 8 Lipid Layer:... 9 Lid-Wiper Epitheliopathy: Meibomian Glands Expression: Meibography: Osmolarity: Tear film stability: Tear meniscus height: Selected Literature:... 15

3 Required technical equipment: ipad Internet connection (for help/support only) Slit lamp microscope TearLab* Meibograph* Tearscope or equivalent* *(optional)

4 Screening Module: The Screening Module calculates dry eye risk of your patient based on subjective and objective observations. In naïve contact lens wearers, this APP can predict likelihood of later dry eye symptoms and of course the APP can analyse contact lens relevant dry eye in experienced lens wearers. Non-Contact Lens Wearer: Please complete the questionnaire together with your patient and start slitlamp microscope observation. You need to use at least one of the listed tear film tests and one of the ocular surface tests. If the test result is at the test`s cut-off value, please press borderline, if the result is more severe please press abnormal. In normal observation please press normal. Based on the patient`s symptoms and your observations the Screening Module automatically calculates likelihood of dry eye. If the result indicates dry eye, please proceed with the Dry Eye Manager. Tests are detailed described in test section. Naïve-Contact Lens Wearer: This is the appropriate procedure if a patient will be fitted with contact-lenses for the first time and you want to know if this patient may suffer from contact lens dry eye in later contact lens wear. Please complete the questionnaire together with your patient and measure the non-invasive break up time (NIBUT, Tearscope with fine grid) and evaluate lid parallel conjunctival folds (LIPCOF). NIBUT is an optional measurement, if you do not have a Tearscope please have a go with LIPCOF, only (please note that video keratometer can measure NIBUT too, but the results are very different to the Tearscope measurements and such you cannot use those here). After having completed this modul the APP calculates the risk of your patient to suffer from contact lens dry eye in later contact lens wear. This is not an exclusion criterion for contact lenses; you simply need to proceed with the Dry Eye Manager to give your patient the best options to improve later wearing comfort. Tests are detailed described in test section.

5 New Contact Lens Wearer: This module analyses contact lens dry eye in experienced contact lens wearers who already wear lenses since at least some month. You do need to complete the questionnaire and to classify lid parallel conjunctival folds (LIPCOF). If this test indicates contact lens dry eye, please proceed with the Dry Eye Manager. Tests are detailed described in test section. Dry Eye Manager: The Dry Eye Manager assists you to classify dry eye type and gives you appropriate managment options for your patient and or it lists the options to remarkable improve contact lens wearing comfort. Please not that you should start with the Dry Eye Manager only after having completed the Dry Eye Screening Module, or you are sure this is a symptomatic dry eye patient. Non-Contact Lens Wearer: Please follow the order of the tests to ensure that you do not influence results. Such first is always the tear film. There are two tests, Meibography and Schirmer I, which are marked as optional, but it is recommended to apply them, if possible. As in the Screening Module, please press borderline if test result is the test`s threshold, otherwise normal for normal measurements or abnormal if more severe than threshold. Tests are detailed described in test section. This module analyses your measurements and classifies dry eye type. Simply click on the marked dry eye type and management recommendations will be shown. Please select the most appropriate management option. You may start with option one followed by two then three, etc. Management success should be measured using for example the Symptometer. Please note: This software aims to assist professionals in the evaluation and management of mild to moderate dry eye. It cannot replace the professional skills and profound knowledge of an eye doctor. Please note the importance of a comprehensive patient history, observations, treatment plans and potential differential diagnoses.

6 Naïve / Experienced Contact Lens Wearer: Pressing the Contact Lens Wearer button leads you to the next menu, in which you can directly go to Contact lens recommendation for optimized contact lens design, fit, material and care. Contact Lens Recommendation: Most promising management options for improved contact lens wearing comfort are shown. This helps you to choose initially the best contact lens options of your naïve contact lens wearer. In an experienced contact lens wearer, please try to change most of the options of the current worn contact lens, which are different to the listed options in the recommendation table. Coexisting Dry Eye: Since in most of the symptomatic lens wearers a generally dry eye disease can be assumed, the evaluation of potential coexisting dry eye is strongly recommended. Coexisting dry eye management combined with optimized lens options will be most effective treating contact lens dry eye. Pease proceed as described in Dry Eye Manager Non Contact Lens Wearer. Since you need to wait 15min to 30min for normalization of the tear film after contact lens removal, you may schedule the patient for an extra dry eye management follow-up (not wearing contact lenses). Symptometer: Use the Symptometer to measure treatment success based on the patient`s symptoms. This also can be used as an extra quick screening module for dry eye. After 1-2 minutes you know the subjective dry eye status of your patient. For example, this can be very helpful in the daily routine of refractions since it is known that dry eye can remarkable impact visual acuity. Also any staff, like assistants or dispensing optician, can use this to easily pre-screen patients. Ocular Surface Disease Index score and dry eye severity are shown in the non-contact lens wearer module. Ratings of results of the contact lens wearer module are not shown.

7 Discomfort Dryness Daily wearing time - comfortable wearing time Table 1: Rating of the Symptometer for contact lens wearers Likely abnormal 3 3 2h Description of Dry Eye Tests: Ocular Surface Disease Index: This is one of the most acknowledged dry eye questionnaires. Please note that this questionnaire ask the patients symptoms retrospectively of the last week. If a question cannot be answered by the patient please mark N/A. To optimize questioning, please interview the patient and fill in the form, instead of the patient. Also please advise the patient to answer spontaneously. You should do so with all questions of the Dry Eye Tool Box Lids: Please observe the lid margins for any meibomian gland orifices plugging, lid margins irregularity, hyperaemia, telangiectasia, posterior migration of gland orifices. Also observe eye lashes for blepharitis which can secondly result in meibomian gland dysfunction (MGD) and consequently abnormal lipid layer. There are different grading scales published, an example for borderline is shown in example image below. If lids are looking normal this does not exclude MGD. Therefore you need to proceed with meibomian gland expression and if possible meibography.

8 Lid-Parallel Conjunctival Folds: Lid-parallel conjunctival folds (LIPCOF) are sub-clinical folds (mild conjunctivochalasis) in the lateral, lower quadrant of the bulbar conjunctiva, parallel to the lower lid margin, easily observable by slit-lamp microscope. LIPCOF are evaluated in the area perpendicular to the temporal and nasal limbus on the bulbar conjunctiva above the lower lid using the slit-lamp microscope (no lens, white light, no fluorescein) using 18 to 27 x magnification as necessary, and classified according to the optimised grading scale. Care should be taken to differentiate between LIPCOF and micro-folds. LIPCOF thickness is commonly 0.08mm (around half of the normal tear meniscus height), while a micro-fold is much smaller at approximately 0.02mm. LIPCOF Sum is adding nasal and temporal LIPCOF scores together (LIPCOF Sum 2 = borderline ).

9 LIPCOF Grade No conjunctival folds 0 One permanent and clear parallel fold 1 Two permanent and clear parallel folds, (normally lower than 0.2mm) 2 More than two permanent and clear parallel folds, (normally higher than 0.2mm) 3 Table 2: LIPCOF grading scale. Lipid Layer: Lipid layer thickness can be observed by classifying colour fringes. This can be done in specular reflection using your slit lamp microscope or using a Tearscope. One grading scale is based on the dominant colour (Table 2) of the inference fringes a more advanced one additional classifying lipid distribution (Table 3).

10 Dominant Colour Lipid layer thickness (nm) Blue 180 Blue/brown 165 Brown/blue 150 Brown 135 Brown/yellow 120 Yellow/brown 105 Yellow 90 Grey/yellow 75 Grey 60 Grey/white 45 White 30 Table 3: Lipid layer grading based on the dominant colour of the colour fringe. Degree Description Open Very thin, poor and minimal lipid layer stretched over the ocular meshwork surface. The darker area is the thinnest Closed More lipid than open meshwork (less stretching of the lipid film), meshwork darker shade of grey represents thinner coverage. Easier to see than open meshwork. Can sometimes be confused with the amorphous pattern however closed meshwork has a more mottled appearance and is not as bright. Wave (flow) Thicker than meshwork with wavy, grey streak effect. This is the most common lipid pattern seen and it represents average tear film stability Amorphous A thick, white even and well mixed lipid layer that may show colours during the blink. Colour fringes Thicker lipid layer with mix of brown and blue colour fringes well spread out over the surface Colour fringes Thicker lipid layer with mix of red and green colour fringes Globular Multiple colours with clumps of lipid that will not spread Table 4: Grading scale of the lipid layer, to be used applying white light illumination like Tearscope.

11 Lid-Wiper Epitheliopathy: LWE is a clinically observable alteration in the epithelium of the advancing lid margin, the lid wiper. LWE is visible using a combination of instilled 1% lissamine green and 2% fluorescein, and is evaluated for the upper lid. A second instillation of both dyes should be carried out after 5 minutes. LWE is classified by width and length. LWE is calculated length + width / 2 (LWE score of 1 = borderline). Care should be taken to differentiate between staining associated with Marx s line and that from staining of the lid wiper. Horizontal length of staining Grade Grade 2 mm mm mm 2 >10 mm 3 Sagittal width of staining Grade 25% of the width of wiper 0 25% 50% of the width of wiper 1 50% 75% of the width of wiper 2 >75% of the width of wiper 3 Table 5: LWE grading scale Meibomian Glands Expression: Please gently express meibomian glands (pressure should be as low as you use for contact lens push up test), best is using the meibomian gland

12 evaluator (Tearlab, USA) of the lower lids nasal, central and temporal portion. If all glands of the lower lid obtain liquid secretion with good quality (fluid and clear) this is normal. Only 6 glands doing so is classified as borderline. This number 6 is dependent on how the data is gathered, being pressure dependent. Digital examination will yield results based on the pressure and technique. Research also shows that for contact lens wearers you likely need a higher number of functional lower lid glands, the highest demand being a hard contact lens. Meibography: Meibogarphy can be done using for example a Finoff transilluminator or more comfortable non-contact infrared meibographs. Any meibomian gland loss of 29% of the lower lid or 17% of the upper lid is borderline (pictorial MeiboScale is available via download:

13 Osmolarity: Osmolaroty of the lower temporal tear meniscus can be measured using the TearLab. The traditional 316 mosm/l threshold was found using an intersection of severe subjects and normals. 308 mosm/l was found to be the most sensitive intersection between mild/moderate and normal subjects such to be classified as borderline. Typically, if someone shows greater than an 8 mosm/l difference between both eyes, it is a good indication of a transition to tear film instability. Tear film stability: There are many methods to measure tear film stability. Best option is noninvasively (NIBUT) using a Tearscope (Keeler, UK) or some new video topographers do have such a tear film analysis option. Please note that topographers and Tearscope measurements are different. Such you cannot use them for the contact lens wearer screening. Please ask your ophthalmic instrument suppliers for such values when using video topographers. Most commonly tear film break up time (TBUT) will be measured by colouring the tear film with fluorescein. Please note that it is fundamental important to not use too much fluorescein (max 2µl). Good option to control this is using a micropipette or the Dry Eye Test@, an extra small fluorescein strip available by Amcon ( Alternatively you can fold the first 1mm of a fluorescein strip (in terms of hygiene please do so in package), this is named the Modified Fluor Strip. Or simply try to touch the superior or inferior temporal bulbar conjunctiva with a fluorescein strip, so that 1 2 mm of the flat side make contact with the ocular surface. Please gently shake the strip before

14 doing so to remove excess fluorescein solution from the strip. Start measuring BUT after a normal blink and it is helpful to use a stop watch. A break-up time of 10sec is reported to be borderline. Tear meniscus height: Height of the lower tear meniscus will be measured (without fluorescein) from a frontal view, perpendicular below the pupil. Please use a reticule or the scale of your slit lamp beam or similar to assure you get proper results. A tear meniscus height of 0.2mm is borderline.

15 Selected Literature: Savini G, Prabhawasat P, Kojima T, Grueterich M, Espana E, Goto E. The challenge of dry eye diagnosis. Clin Ophthalmol 2008;2: Sullivan BD, Crews LA, Sonmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea 2012;31: Lemp MA, Bron AJ, Baudouin C, Benitez Del Castillo JM, Geffen D, Tauber J, Foulks GN, Pepose JS, Sullivan BD. Tear osmolarity in the diagnosis and management of dry eye disease. Am J Ophthalmol 2011;151:792-8 e1. 4. McGinnigle S, Naroo SA, Eperjesi F. Evaluation of Dry Eye. Survey of Ophthalmology 2012;57: Craig JP, Willcox MD, Argueso P, Maissa C, Stahl U, Tomlinson A, Wang J, Yokoi N, Stapleton F, members of TIWoCLD. The TFOS International Workshop on Contact Lens Discomfort: Report of the Contact Lens Interactions With the Tear Film Subcommittee. Invest Ophthalmol Vis Sci 2013;54:TFOS Dumbleton K, Caffery B, Dogru M, Hickson-Curran S, Kern J, Kojima T, Morgan PB, Purslow C, Robertson DM, Nelson JD, members of the TIWoCLD. The TFOS International Workshop on Contact Lens Discomfort: Report of the Subcommittee on Epidemiology. Invest Ophthalmol Vis Sci 2013;54:TFOS Efron N, Jones L, Bron AJ, Knop E, Arita R, Barabino S, McDermott AM, Villani E, Willcox MD, Markoulli M, members of the TIWoCLD. The TFOS International Workshop on Contact Lens Discomfort: Report of the Contact Lens Interactions With the Ocular Surface and Adnexa Subcommittee. Invest Ophthalmol Vis Sci 2013;54:TFOS98- TFOS Foulks G, Chalmers R, Keir N, Woods CA, Simpson T, Lippman R, Gleason W, Schaumberg DA, Willcox MD, Jalbert I, members of the TIWoCLD. The TFOS International Workshop on Contact Lens Discomfort: Report of the Subcommittee on Clinical Trial Design and Outcomes. Invest Ophthalmol Vis Sci 2013;54:TFOS Jones L, Brennan NA, Gonzalez-Meijome J, Lally J, Maldonado-Codina C, Schmidt TA, Subbaraman L, Young G, Nichols JJ, members of the TIWoCLD. The TFOS International Workshop on Contact Lens Discomfort: Report of the Contact Lens Materials, Design, and Care Subcommittee. Invest Ophthalmol Vis Sci 2013;54:TFOS Nichols JJ, Jones L, Nelson JD, Stapleton F, Sullivan DA, Willcox MD, members of the TIWoCLD. The TFOS International Workshop on Contact Lens Discomfort: Introduction. Invest Ophthalmol Vis Sci 2013;54:TFOS Nichols JJ, Willcox MD, Bron AJ, Belmonte C, Ciolino JB, Craig JP, Dogru M, Foulks GN, Jones L, Nelson JD, Nichols KK, Purslow C, Schaumberg DA, Stapleton F, Sullivan DA, members of the TIWoCLD. The TFOS International Workshop on Contact Lens Discomfort: Executive Summary. Invest Ophthalmol Vis Sci 2013;54:TFOS7-TFOS Nichols KK, Redfern RL, Jacob JT, Nelson JD, Fonn D, Forstot SL, Huang JF, Holden BA, Nichols JJ, members of the TIWoCLD. The TFOS International Workshop on Contact Lens Discomfort: Report of the Definition and Classification Subcommittee. Invest Ophthalmol Vis Sci 2013;54:TFOS Papas EB, Ciolino JB, Jacobs D, Miller WS, Pult H, Sahin A, Srinivasan S, Tauber J, Wolffsohn JS, Nelson JD, members of the TIWoCLD. The TFOS International Workshop on Contact Lens Discomfort: Report of the Management and Therapy Subcommittee. Invest Ophthalmol Vis Sci 2013;54:TFOS

16 14. Stapleton F, Marfurt C, Golebiowski B, Rosenblatt M, Bereiter D, Begley C, Dartt D, Gallar J, Belmonte C, Hamrah P, Willcox M, Discomfort TIWoCL. The TFOS International Workshop on Contact Lens Discomfort: Report of the Subcommittee on Neurobiology. Invest Ophthalmol Vis Sci 2013;54:TFOS Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The International Workshop on Meibomian Gland Dysfunction: Report of the Subcommittee on Management and Treatment of Meibomian Gland Dysfunction. Investigative Ophthalmology & Visual Science 2011;52: Green-Church KB, Butovich I, Willcox M, Borchman D, Paulsen F, Barabino S, Glasgow BJ. The International Workshop on Meibomian Gland Dysfunction: Report of the Subcommittee on Tear Film Lipids and Lipidâ Protein Interactions in Health and Disease. Investigative Ophthalmology & Visual Science 2011;52: Knop E, Knop N, Millar T, Obata H, Sullivan DA. The International Workshop on Meibomian Gland Dysfunction: Report of the Subcommittee on Anatomy, Physiology, and Pathophysiology of the Meibomian Gland. Investigative Ophthalmology & Visual Science 2011;52: Nelson JD, Shimazaki J, Benitez-del-Castillo JM, Craig JP, McCulley JP, Den S, Foulks GN. The International Workshop on Meibomian Gland Dysfunction: Report of the Definition and Classification Subcommittee. Invest Ophthalmol Vis Sci 2011;52: Nichols KK. The International Workshop on Meibomian Gland Dysfunction: Introduction. Investigative Ophthalmology & Visual Science 2011;52: Nichols KK, Foulks GN, Bron AJ, Glasgow BJ, Dogru M, Tsubota K, Lemp MA, Sullivan DA. The International Workshop on Meibomian Gland Dysfunction: Executive Summary. Invest Ophthalmol Vis Sci 2011;52: Schaumberg DA, Nichols JJ, Papas EB, Tong L, Uchino M, Nichols KK. The International Workshop on Meibomian Gland Dysfunction: Report of the Subcommittee on the Epidemiology of, and Associated Risk Factors for, MGD. Investigative Ophthalmology & Visual Science 2011;52: Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The International Workshop on Meibomian Gland Dysfunction: Report of the Diagnosis Subcommittee. Investigative Ophthalmology & Visual Science 2011;52: Hinkle DM. Lid wiper epitheliopathy and dry eye symptoms. Eye Contact Lens 2006;32:160; author reply 24. Knop E, Korb DR, Blackie CA, Knop N. The lid margin is an underestimated structure for preservation of ocular surface health and development of dry eye disease. Dev Ophthalmol 2010;45: Korb DR, Greiner JV, Herman JP, Hebert E, Finnemore VM, Exford JM, Glonek T, Olson MC. Lid-wiper epitheliopathy and dry-eye symptoms in contact lens wearers. CLAO J 2002;28: Korb DR, Herman JP, Blackie CA, Scaffidi RC, Greiner JV, Exford JM, Finnemore VM. Prevalence of lid wiper epitheliopathy in subjects with dry eye signs and symptoms. Cornea 2010;29: Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol 2000;118: Nichols KK, Smith JA. Association of clinical diagnostic tests and dry eye surveys: the NEI-VFQ-25 and the OSDI. Adv Exp Med Biol 2002;506: Hoh H, Schirra F, Kienecker C, Ruprecht KW. Lid-parallel conjunctival folds (LIPCOF): A definite diagnostic sign of dry eye. Ophthalmologe 1995;92:802-8.

17 30. Pult H, Murphy PJ, Purslow C. The longitudinal impact of soft contact lens wear on lid wiper epitheliopathy and lid-parallel conjunctival folds. In: 6th International Conference on the Tear Film & Ocular Surface: Basic Science and Clinical Relevance. Florence, Italy; Pult H, Murphy PJ, Purslow C. A novel method to predict the dry eye symptoms in new contact lens wearers. Optom Vis Sci 2009;86:E Pult H, Purslow C, Berry M, Murphy PJ. Clinical tests for successful contact lens wear: relationship and predictive potential. Optom Vis Sci 2008;85:E Pult H, Purslow C, Murphy PJ. P-Test: The New Standard to Predict the Dry Eye Symptoms in New Contact Lens Wearers? Investigative Ophthalmology & Visual Science 2009;50:ARVO E-Abstract: Pult H, Purslow C, Murphy PJ. The relationship between clinical signs and dry eye symptoms. Eye (Lond) 2011;25: Pult H, Purslow C, Murphy PJ, Berry M. Lid wiper epitheliopathy, ocular surface and tear film in symptomatic contact lens wearers. Acta Ophthalmologica 2008;86: Guillon JP. Use of the Tearscope Plus and attachments in the routine examination of the marginal dry eye contact lens patient. Adv Exp Med Biol 1998;438: Guillon JP. Non-invasive Tearscope Plus routine for contact lens fitting. Cont Lens Anterior Eye 1998;21 Suppl 1:S King-Smith PE, Fink BA, Fogt N. Three interferometric methods for measuring the thickness of layers of the tear film. Optom Vis Sci 1999;76: Keech A, Senchyna M, Jones L. Impact of time between collection and collection method on human tear fluid osmolarity. Curr Eye Res 2013;38: Pult H, Bandlitz S. Leitfaden Trockenes Auge. Der Augenoptiker 2012;10: Pult H, Riede-Pult BH. A new modified fluorescein strip: Its repeatability and usefulness in tear film break-up time analysis. Contact Lens and Anterior Eye 2012;35:35-8.

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